Phase III
Ayala announced positive data for its desmoid tumor treatment, while Vertex and Dyne announced the FDA had lifted the hold on their clinical studies.
DiaMedica Therapeutics’ Phase II/III ReMEDy2 trial is on hold by the FDA because patients were experiencing severe drops in blood pressure.
Intercept Pharmaceuticals, Annovis Bio and Biohaven Pharma are moving forward with late-stage Phase III clinical trials.
Lysogene’s Phase II/III trial assessing LYS-SAF302 for the treatment of MPS IIIA, also known as Sanfilippo syndrome type A, revealed positive biomarker data, spurring hope for a potential treatment.
As the global life sciences industry slows down, companies are gathering money through means other than VC funding. BioSpace shines a light on some of these recent transactions.
Mogrify and Astellas have forged a collaboration surrounding in vivo regenerative medicine approaches, while CardiNor inked a distribution deal with IBL-America.
Veru Inc. has announced the publication of positive Phase III results from its COVID-19 antiviral therapeutics that could lead to potential Emergency Use Authorization.
Eisai and Biogen’s BLA for lecanemab for Alzheimer’s disease received FDA Priority Review with a target action date of January 6, 2023, while Roche’s lymphoma drug scored the same designation.
Seagen announced positive data from its Phase II trial in colorectal cancer, and the FDA provided positive feedback supporting a Phase IIIb trial for ANeuroTech’s MDD drug.
Otsuka and Lunbeck report positive Phase III results in agitation in Alzheimer’s, Acer’s vEDS program hits Phase III and BridgeBio’s primary hyperoxaluria type 1 program progresses.
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